# FDA recall Z-1216-2024

> **United Orthopedic Corporation** · Class II · device recall initiated 2024-01-03.

## Product

USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers:    REF: PE25153109 - 9x125mm,	PE25153209 - 9x150mm,	PE25153113 - 13x125mm,	PE25153111- 11x125mm,	PE25153115 - 15x125mm,	PE25153211 - 11x150mm, 	PE25153213 - 13x150mm,	PE25153217 - 17x150mm,	PE25153117 - 17x125mm,	PE25153015 - 15x100mm,	PE25153215 - 15x150mm

## Reason for recall

Their is a potential that the implant curved stem  may be oriented incorrectly.

## Distribution

US: CA,KY, MI, IN, TN, CO, FL, TX, NV,  OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan

## Key facts

- **Recall number:** Z-1216-2024
- **Recalling firm:** United Orthopedic Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-03
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hsinchu, Taiwan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2024

## Citation

> AI Analytics. FDA recall Z-1216-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1216-2024. Source: US FDA. Licensed CC0.

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